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Trigen

Model XT001037-1 · Smith & Nephew, Inc. · DI 00885556650172

JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2020-06-24Z-2685-2020Class IITerminatedA manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.k number procode

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23572019-01: 0 reports for this device; peer average 1.43/device2019-02: 0 reports for this device; peer average 1.65/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 1.14/device2019-05: 0 reports for this device; peer average 2.3/device2019-06: 0 reports for this device; peer average 1.88/device2019-07: 0 reports for this device; peer average 2.4/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1.27/device2019-10: 0 reports for this device; peer average 2.07/device2019-11: 0 reports for this device; peer average 2.36/device2019-12: 0 reports for this device; peer average 2.08/device2020-01: 0 reports for this device; peer average 1.4/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 1.67/device2020-04: 0 reports for this device; peer average 1.86/device2020-05: 0 reports for this device; peer average 1.25/device2020-06: 0 reports for this device; peer average 2.25/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.88/device2020-09: 0 reports for this device; peer average 2.78/device2020-10: 0 reports for this device; peer average 1.9/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1.65/device2021-01: 0 reports for this device; peer average 1.71/device2021-02: 0 reports for this device; peer average 1.83/device2021-03: 0 reports for this device; peer average 1.89/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2.13/device2021-06: 0 reports for this device; peer average 1.87/device2021-07: 0 reports for this device; peer average 1.79/device2021-08: 0 reports for this device; peer average 3.06/device2021-09: 0 reports for this device; peer average 1.96/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.78/device2021-12: 0 reports for this device; peer average 2.18/device2022-01: 0 reports for this device; peer average 2.07/device2022-02: 0 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 1.9/device2022-04: 0 reports for this device; peer average 1.68/device2022-05: 0 reports for this device; peer average 1.7/device2022-06: 0 reports for this device; peer average 2.42/device2022-07: 0 reports for this device; peer average 2.22/device2022-08: 0 reports for this device; peer average 2.4/device2022-09: 0 reports for this device; peer average 3.96/device2022-10: 0 reports for this device; peer average 3.06/device2022-11: 0 reports for this device; peer average 3.82/device2022-12: 0 reports for this device; peer average 3.08/device2023-01: 0 reports for this device; peer average 3.14/device2023-02: 0 reports for this device; peer average 3.93/device2023-03: 0 reports for this device; peer average 4.56/device2023-04: 0 reports for this device; peer average 3.09/device2023-05: 0 reports for this device; peer average 4.53/device2023-06: 0 reports for this device; peer average 4.15/device2023-07: 0 reports for this device; peer average 3.1/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 1.82/device2023-10: 0 reports for this device; peer average 1.81/device2023-11: 0 reports for this device; peer average 1.33/device2023-12: 0 reports for this device; peer average 1.85/device2024-01: 0 reports for this device; peer average 2.88/device2024-02: 0 reports for this device; peer average 1.81/device2024-03: 0 reports for this device; peer average 2.18/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 1.67/device2024-06: 0 reports for this device; peer average 2.25/device2024-07: 0 reports for this device; peer average 1.5/device2024-08: 0 reports for this device; peer average 1.88/device2024-09: 0 reports for this device; peer average 2.21/device2024-10: 0 reports for this device; peer average 2.38/device2024-11: 0 reports for this device; peer average 3.08/device2024-12: 0 reports for this device; peer average 2.59/device2025-01: 0 reports for this device; peer average 3.33/device2025-02: 0 reports for this device; peer average 2.75/device2025-03: 0 reports for this device; peer average 2.54/device2025-04: 0 reports for this device; peer average 6.64/device2025-05: 0 reports for this device; peer average 2.89/device2025-06: 0 reports for this device; peer average 2.2/device2025-07: 0 reports for this device; peer average 3.18/device2025-08: 0 reports for this device; peer average 2.61/device2025-09: 0 reports for this device; peer average 3.09/device2025-10: 0 reports for this device; peer average 3.22/device2025-11: 0 reports for this device; peer average 3.29/device2025-12: 0 reports for this device; peer average 3.93/device2026-01: 0 reports for this device; peer average 2.75/device2026-02: 0 reports for this device; peer average 3.13/device2026-03: 0 reports for this device; peer average 2.2/device2026-04: 0 reports for this device; peer average 2.07/device2026-05: 0 reports for this device; peer average 2.58/device2026-06: 0 reports for this device; peer average 2.43/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.43
2019-0201.65
2019-0301.25
2019-0401.14
2019-0502.3
2019-0601.88
2019-0702.4
2019-0802
2019-0901.27
2019-1002.07
2019-1102.36
2019-1202.08
2020-0101.4
2020-0202.17
2020-0301.67
2020-0401.86
2020-0501.25
2020-0602.25
2020-0701.85
2020-0801.88
2020-0902.78
2020-1001.9
2020-1102
2020-1201.65
2021-0101.71
2021-0201.83
2021-0301.89
2021-0402
2021-0502.13
2021-0601.87
2021-0701.79
2021-0803.06
2021-0901.96
2021-1002
2021-1101.78
2021-1202.18
2022-0102.07
2022-0202.5
2022-0301.9
2022-0401.68
2022-0501.7
2022-0602.42
2022-0702.22
2022-0802.4
2022-0903.96
2022-1003.06
2022-1103.82
2022-1203.08
2023-0103.14
2023-0203.93
2023-0304.56
2023-0403.09
2023-0504.53
2023-0604.15
2023-0703.1
2023-0802.11
2023-0901.82
2023-1001.81
2023-1101.33
2023-1201.85
2024-0102.88
2024-0201.81
2024-0302.18
2024-0401.83
2024-0501.67
2024-0602.25
2024-0701.5
2024-0801.88
2024-0902.21
2024-1002.38
2024-1103.08
2024-1202.59
2025-0103.33
2025-0202.75
2025-0302.54
2025-0406.64
2025-0502.89
2025-0602.2
2025-0703.18
2025-0802.61
2025-0903.09
2025-1003.22
2025-1103.29
2025-1203.93
2026-0102.75
2026-0203.13
2026-0302.2
2026-0402.07
2026-0502.58
2026-0602.43
This device (reports/month)Average device in JDS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K061019 — cited as predicate by K092748, K102369, K111667, K150867, K171108, K210980, K230761, K240061

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations